AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL

Sponsor
Ruijin Hospital
Study ID
NCT07594899
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Large B-Cell Lymphoma (LBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
  • rituximab — DRUG
    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
  • Cyclophosphamide — DRUG
    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
  • Doxorubicin — DRUG
    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
  • Prednisone — DRUG
    Prednisone PO will be administered as per the schedule specified in the respective arm.
  • Zanubrutinib — DRUG
    Zanubrutinib PO will be administered as per the schedule specified in the respective arm.
  • Lenalidomide — DRUG
    Lenalidomide PO will be administered as per the schedule specified in the respective arm.
  • Decitabine — DRUG
    Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
  • Glofitamab — DRUG
    Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.

Study Details

This is a prospective, open-label, multicenter, randomized controlled study in participants with previously untreated large B-cell lymphoma. Participants will be stratified into different risk groups using an AI-based multimodal model. Those classified as intermediate- or high-risk will be randomized in a 1:1 ratio to receive either an AI-guided treatment strategy or Pola-R-CHP. In the experimental arm, participants will receive either genotype-guided targeted agents in combination with Pola-R-CHP or Pola-R-CHP combined with glofitamab, according to their AI-defined risk group and molecular features. Participants in the control arm will receive Pola-R-CHP. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with Pola-R-CHP.

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP
    Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2, doxorubicin 50 mg/m² IV on Day 2, and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of the first 21-day cycle. For the remaining five cycles, participants will receive standard Pola-R-CHP in combination with one of the following: zanubrutinib 160 mg BID PO on Days 1-21, lenalidomide 25 mg/day PO on Days 2-11, decitabine 10 mg/m²/day IV on Days -5 to -1, or glofitamab administered IV with step-up dosing of 2.5 mg on Cycle 2 Day 8, 10 mg on Cycle 2 Day 15, and 30 mg on Day 8 of Cycles 3-6. Each treatment cycle is 21 days.
  • Active Comparator: Pola-R-CHP
    Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2, doxorubicin 50 mg/m² IV on Day 2, and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for 6 cycles.

Primary Outcome Measure

Progression-free survival [ Time Frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months) ]

Central Contacts

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